Cardiola receives EU approval for home cardiac counterpulsation
27 May 2009
Cardiola AG has received CE Mark recertification to market its
m.pulse system for at-home use to treat chronic heart failure (CHF), the
most frequent cause of hospitalization in persons over 65.
Current treatments for CHF, including drugs, implantable
defibrillators/pumps and heart transplantation, have significant risks
and side effects. Cardiola’s m.pulse system, based on muscular
counterpulsation (MCP) technology, has been recertified in Europe for
treating CHF as a nonsurgical, at-home therapy.
The phone-sized m.pulse is attached to the patient's belt for about
45 minutes per treatment. It is synchronized to the patient's cardiac
cycle to stimulate the muscles of the calves and thighs to make them
contract counter to the heart’s beating.
This well-established counterpulsation action results in increased
blood flow to the heart muscle while decreasing the heart’s workload.
Counterpulsation was previously only available in a clinical setting.
“Clinical evidence, published in peer-reviewed medical journals, has
demonstrated that MCP — the proprietary technology platform of our
patented m.pulse device — facilitates timely and effective therapy,
improving outcomes for CHF patients,” said Christof Lenz, Cardiola’s CEO
and former Global Innovation Manager at Siemens Medical.
“We are extremely pleased that our m.pulse system has been cleared
for marketing in Europe as a well-validated, affordable and non-surgical
treatment alternative that patients themselves can perform in their own
Chronic Heart Failure is among the world’s most prevalent diseases
and the cause of numerous other serious clinical disorders.
Approximately 17 million people currently suffer from CHF in Europe, the
US and Japan. Some six million of these patients are classified as NYHA
(New York Heart Assn.) classes II and III with systolic dysfunction, the
primary patient population for m.pulse.
Bookmark this page